JP6348052B2 - Medical materials - Google Patents

Description

  The present invention relates to a medical material for treating a defect hole, an aneurysm, or the like formed in a living tissue, and in particular, for medical use that is set in a catheter, sent to a treatment site through a blood vessel, and placed in the living body. Regarding materials.

  The human heart is divided into left and right rooms by an organization called a septum, which has an atrium and a ventricle on each of the left and right sides, and is composed of two atriums and two ventricles: a right atrium, a right ventricle, a left atrium, and a left ventricle. In a heart having such a structure, an atrial septal defect (ASD) in which a hole called a defect hole is congenitally opened in the atrial septum separating the right atrium and the left atrium due to a developmental disorder in the fetal period. Defect).

There are two methods for treating this atrial septal defect as shown below. One is a surgical operation performed by cutting the chest, and the other is a catheter treatment using an obturator without cutting the chest.
In the surgical operation (patch operation), an artificial heart-lung machine is used, the chest is opened, and the defect hole is closed with a patch. In the catheter treatment, a closure plug is set on the catheter, the catheter is inserted into a blood vessel, sent to a target position (defect hole), and then the closure plug is released and placed in the body. In this catheter treatment, a small jig (device) called an oblong closure plug is sent from the vein at the base of the foot (femoral vein) to the position of the hole opened in the atrial septum without closing the chest, and the hole is closed. Is. The advantage of this catheter treatment is that it can be treated with a very small skin incision (several millimeters) from an inconspicuous place at the base of the foot (skin) without performing thoracotomy that requires general anesthesia. .

  Japanese translations of PCT publication No. 2008-512139 (patent document 1) discloses an assembly (closure plug) used for catheter treatment of atrial septal defect. This assembly seals the heart passage (defect hole). The assembly extends through a passageway, a first anchor used for placement proximal to the first end of the passageway, a second anchor used for placement proximal to the second end of the passageway, and the passageway. A closure device for sealing the heart passage including a flexible extension used to couple to the first and second anchors, the second anchor being movable relative to the flexible extension And a supply system for changing the length of the flexible extension between the second anchor and supplying the closure device to the heart passage, the supply device being configured to move through the lumen of the guide catheter A wire for controlling movement along the flexible extension of the second anchor.

  And in this patent document 1, a patent foramen foramen (PFO: Patent Oval Foramen) closing device (closure plug) includes a left atrial anchor, a right atrial anchor, a tether and a lock, and via the left atrial anchor and the tether. It is disclosed that the right atrial anchor and lock that couple to the left atrial anchor remain in the heart and seal the PFO.

Special table 2008-512139 gazette

In the case of patch surgery, there is a problem that the cardiopulmonary lung is used and the hospitalization period becomes long due to high invasiveness. In the case of catheter treatment, an artificial heart-lung machine is not used, and since the invasiveness is low, the hospitalization period is short and preferable.
As disclosed in Patent Document 1, the left atrial anchor and the right atrial anchor remain in the heart. And the left atrial anchor and the right atrial anchor include one or more arms, the arms extending radially outward from the hub, preferably formed from a rolled sheet of binary nickel titanium alloy. Has been. The left atrial anchor and the right atrial anchor are expanded in vivo to close the defect hole. However, once the expansion of the anchor is started, it cannot be easily restored. The anchor is folded using a dedicated take-out device that has a complicated structure and is difficult to operate from outside the living body as disclosed in Patent Document 1.

However, for example, when the anchor is caught by a living tissue in the atrium and is damaged, there is a case where there is not enough time to fold the anchor with such a dedicated extraction device. In such a case, it is unavoidable to immediately switch to thoracotomy. In this case, there is a problem in that a thoracotomy is highly invasive.
Furthermore, since the metal defect hole closure plug remains in the body for a lifetime, there is a problem that there is a concern about a malfunction in the remote period.

In addition to such defect holes, there are aneurysms formed in various parts of the living body as diseases to which catheter treatment is applied. Such an aneurysm also has the same problems as those described above.
The present invention has been developed in view of the above-mentioned problems of the prior art, and its object is to perform a minimally invasive catheter treatment that can be released and placed at a treatment site in a living body with a complicated structure. An object of the present invention is to provide a medical material that can be easily operated without any preparation and has almost no possibility of a remote failure even if it remains in the body.

In order to achieve the above object, the medical material according to the present invention takes the following technical means.
That is, the medical material according to the present invention is a medical material formed by a tubular body having a knitted structure using a wire, and the cylindrical diameter of the substantially central portion of the cylindrical body is larger than the cylindrical diameter of other portions. And the stitch structure at both ends in the longitudinal direction of the cylindrical body of the medical material forms a first aggregated part with one end protruding toward the outside of the cylindrical body, and the other A second assembly portion having a shape in which an end is dented toward the inside of the cylindrical body is formed.

Preferably, the first end of the medical material in the longitudinal direction of the cylindrical body is fixed and the second end which is the other end is pulled toward the first end. It can comprise so that a cylinder diameter may be expanded.
More preferably, the substantially central portion and a second tubular portion first tubular portion of the first end portion side in the center and the second end side is formed, a pre-Symbol first end By fixing and pulling the second end portion, which is the other end portion, toward the first end portion side, the first tube portion and the second tube portion approach each other around the substantially central portion. Can be configured to.

More preferably, it may be configured to further include a string that is engaged with the second end portion and passed through the inside of the cylindrical body to the first end portion side.
More preferably, the first end portion having a shape protruding toward the outside of the cylindrical body is provided on the first end portion side, and the first end portion is recessed toward the inner side of the cylindrical body on the second end portion side. It can comprise so that the shape 2nd collection part may be provided.

More preferably, the substantially central portion and a second tubular portion first tubular portion of the first end portion side in the center and the second end side is formed, a pre-Symbol first end By fixing and pulling the substantially central portion side of the first tube portion toward the first end portion, the tube diameter of the first tube portion can be expanded.
More preferably, it can be configured to further include a string that is engaged with the substantially central portion side of the first tubular portion and passed through the inside of the tubular body up to the first end portion side.

  More preferably, a first tube portion on the first end side and a second tube portion on the second end portion side are formed around the substantially central portion, and the first end portion side is formed from the first end portion side. The first end is passed through the inside of the cylinder to the second end side, is engaged with the second end and is passed through the inside of the cylinder to the first end side. And is again passed to the inside of the cylinder up to the second end side, re-engaged to the second end and passed again to the inside of the cylinder to the first end side. It can comprise so that a string may be provided.

More preferably, a first tube portion on the first end side and a second tube portion on the second end portion side are formed around the substantially central portion, and the first end portion side is formed from the first end portion side. The second end portion is passed through the inside of the cylindrical body, is engaged with the second end portion, is passed through the cylindrical body up to the substantially central portion, and is engaged with the substantially central portion. A string that is re-passed through the cylinder to the second end, re-engaged with the second end, and re-passed through the cylinder to the first end Can be configured.

More preferably, the said shape can be comprised so that it may be an hourglass type | mold, an 8-shaped type, or a double spindle type.
More preferably, the wire can be configured to be a bioabsorbable material.
More preferably, a porous cylindrical layer made of any one of a nonwoven fabric, a sponge, a film and a composite made of a bioabsorbable material may be arranged on the inner surface of the cylindrical body. it can.

  According to the medical material of the present invention, a minimally invasive catheter treatment that can be released and placed at a treatment site in a living body can be performed with an easy operation without a complicated structure. Furthermore, according to the medical material of the present invention, even if it remains in the body, there is almost no possibility of a malfunction in the remote period.

It is a whole perspective view of the defect hole closure material which is an example of the medical material concerning the present invention. (A) is the partial side view of the defect hole closing material of FIG. 1, (B) is the AA sectional drawing. It is a conceptual diagram in the case of using the defect hole closing material of FIG. 1 for the catheter treatment of atrial septal defect. FIG. 4 is an enlarged view (No. 1) of a part B of FIG. 3 showing a procedure for catheter treatment. FIG. 4 is an enlarged view (No. 2) of part B of FIG. 3 showing the procedure of catheter treatment. FIG. 4 is an enlarged view (No. 3) of part B of FIG. 3 showing the procedure of catheter treatment. FIG. 4 is an enlarged view (No. 4) of part B of FIG. 3 showing the procedure of catheter treatment. FIG. 6 is an enlarged view (No. 5) of a part B in FIG. 3 showing a procedure for catheter treatment. It is a figure (the 1) which shows the procedure of the catheter treatment with respect to an aneurysm. It is FIG. (2) which shows the procedure of the catheter treatment with respect to an aneurysm. It is FIG. (The 3) which shows the procedure of the catheter treatment with respect to an aneurysm. It is a whole perspective view of the defect hole closure material which is an example of the medical material which concerns on the 1st modification of this invention. It is a whole perspective view of the defect hole closure material which is an example of the medical material which concerns on the 2nd modification of this invention.

  Hereinafter, the medical material according to the present invention will be described in detail with reference to the drawings. In the following, a defect hole closing material used for catheter treatment will be described as an example of the medical material according to the present invention, but other openings or passages such as a ventricular septal defect, a heart such as a patent duct for arterial duct, etc. It is also suitable for other openings of the body, and for opening or closing passages of other parts of the body (eg stomach) such as arteriovenous fistula. Therefore, the defect hole closing material according to the embodiment of the present invention is not limited to use for closing a hole of an atrial septal defect. In particular, the present invention can be applied to catheter treatment for other diseases as well as being applicable to catheter treatment of aneurysms as described as other modes of use.

Furthermore, in the following embodiment, although the stitch-like structure of the defect hole closing material 100 is described as a knitted bioabsorbable fiber (an example of a wire), the present invention is not limited to this. Any defect hole closing material capable of performing a catheter treatment for closing a defect hole formed in a living body may be used, and the knitted tissue has a first feature and a second feature to be described later. It may be knitted with a wire other than the bioabsorbable fiber as long as it exhibits a function. As such a wire rod, it is preferable to have a certain degree of hardness in order to provide form retention.
[Constitution]
FIG. 1 is an overall perspective view of a defect hole closing material (closing plug) 100 according to the present embodiment, FIG. 2 (A) is a partial side view of the defect hole closing material 100, and FIG. FIG. 2A is a cross-sectional view taken along line AA in FIG. 2B is a cross-sectional view of the defect hole closing material 100, but only the cross-sections of the string 140, the bioabsorbable fiber 150, and the porous cylindrical layer 160 are illustrated and viewed from the direction indicated by the arrow A. The stitches of the bioabsorbable fiber 150 that can be formed are not shown. 1 and 2, the porous cylindrical layer 160 is illustrated as a transparent material in order to facilitate understanding of the presence of the string 140 and the stitches of the bioabsorbable fiber 150.

  As shown in these drawings, the defect hole closing material 100 is formed by two cylindrical bodies (a first cylindrical portion 110 and a second cylindrical portion 120) of a knitted tissue using a bioabsorbable material. The shape is composed of such two cylindrical bodies, for example, an hourglass shape, an 8-shaped shape, a double spindle type (a shape in which two spindle-shaped objects are formed in the middle of a long and slender bar shape and are thick at both ends). ) Or peanut type (appearance shape of peanut shell containing two grains). The defect hole closing material 100 having such a shape has a shape in which the substantially central portion 130 is narrowed so that the cylindrical diameter of the substantially central portion 130 of the cylindrical body is smaller than the cylindrical diameter of other portions. That is, the first tube portion 110 on the first end portion 112 side and the second tube portion 120 on the second end portion 122 side are formed around the substantially central portion 130.

  Although not limited, the defect hole closing material 100 is formed after the first cylindrical portion 110 and the second cylindrical portion 120 are integrally knitted to form a cylindrical body having substantially the same diameter. An hourglass type, an eight-shaped type, a double spindle type, or a peanut made up of two cylindrical bodies that are squeezed at a substantially central portion 130 by a string of the same material as the first cylindrical portion 110 and the second cylindrical portion 120 Formed into a mold.

  Further, the defect hole closing material 100 is engaged with the second end portion 122 (hooked by the loop of the second end portion 122), and passed through the inside of the cylindrical body to the first end portion 112 side. A string 140 is provided. By using the string 140, the first end 112 in the longitudinal direction of the cylindrical body in the defect hole closing material 100 is fixed, and the second end 122, which is the other end, is fixed to the first end 112 side. Can be pulled to. By pulling the second end portion 122 toward the first end portion 112 using the string 140 in this manner, the tube diameter of the other portion of the substantially central portion 130 (the first tube portion 110 and the second tube portion). The cylinder diameter of the body portion of the portion 120 is expanded, or the first cylinder portion 110 and the second cylinder portion 120 approach each other about the substantially central portion 130.

  In this defect hole closing material 100, a porous cylindrical layer 160 made of any one of a nonwoven fabric, a sponge, a film, and a composite made of a bioabsorbable material is disposed on the inner surface of the cylindrical body. Yes. The 1st cylinder part 110 and the 2nd cylinder part 120 are comprised by the knitted fabric of the bioabsorbable fiber 150, a braided woven fabric, or a cylindrical knitted fabric, and the whole is made into the stitch-like structure | tissue. The porous cylindrical layer 160 is composed of any one of a nonwoven fabric, a sponge, a film, or a composite thereof in order to hold a drug by application, impregnation, embedding, or the like. Further, the porous cylindrical layer 160 is not limited to the bioabsorbable material, and may be a material that is not absorbed by the living body.

  As described above, the defect hole closing material 100 according to the present embodiment is constituted by the first cylindrical portion 110, the second cylindrical portion 120, the string 140 (including a string that squeezes the substantially central portion 130), and the porous cylindrical layer 160. Is configured. Since these materials are all composed of a bioabsorbable material, the entire defect hole closing material 100 is bioabsorbable. Furthermore, although the shape of the defect hole closing material 100 changes, it is formed of a material, a stitch shape, a fiber tissue, and a fiber cross section that does not damage the tissue in the living body even if the shape changes in the living body. Yes. Normally, the string 140 is taken out of the living body after the catheter treatment described later is completed. In this regard, the string 140 need not necessarily be bioabsorbable.

  The bioabsorbable fibers 150 constituting the first cylinder part 110, the second cylinder part 120, and the string 140 (including the string that squeezes the substantially central part 130) are, for example, polyglycolic acid, polylactide (D, L , DL form), polycaprolactone, glycolic acid-lactide (D, L, DL form) copolymer, glycolic acid-ε-caprolactone copolymer, lactide (D, L, DL form) -ε-caprolactone copolymer , Poly (p-dioxanone), glycolic acid-lactide (D, L, DL) -ε-caprolactone copolymer, gelatin, collagen, silk (sericin) and the like, and a monofilament yarn, Although it is used in a form processed into any of multifilament yarn, twisted yarn, braided string, etc., it is preferably used in the form of monofilament yarn.

Furthermore, the material of the bioabsorbable fiber 150 may be a biodegradable alloy. An example of such a biodegradable alloy is an alloy based on magnesium as a raw material.
The diameter of the bioabsorbable fiber 150 is about 0.001 mm to 1.5 mm, and a fiber diameter and type appropriate for the applied catheter treatment are selected. Moreover, the cross section of the bioabsorbable fiber 150 may be any of a circle, an ellipse, and other irregular shapes (for example, a star shape) as long as the tissue in the living body is not damaged. Further, the surface of the bioabsorbable fiber 150 may be hydrophilized by plasma discharge, electron beam treatment, corona discharge, ultraviolet irradiation, ozone treatment, or the like. The bioabsorbable fiber 150 is suitable for application of radiopaque material (for example, barium sulfate, gold chip, platinum chip, etc.), sputtering or impregnation treatment, and medicine (for example, catheter treatment of atrial septal defect). Or a natural polymer such as collagen or gelatin, or a synthetic polymer such as polyvinyl alcohol or polyethylene glycol.

  The first tube portion 110 and the second tube portion 120 include a plurality of (for example, eight ports) of bioabsorbable fibers 150 around a silicone rubber tube (not shown) having an outer diameter desired as a monofilament thread, for example. Alternatively, a braided machine having a yarn feeder having 12 yarns) is manufactured into a braided woven fabric, or is knitted into a tubular knitted structure having a substantially same diameter by a circular knitting machine (not shown). After knitting, as described above, the hourglass shape, which is composed of two cylindrical bodies, is squeezed at the substantially central portion 130 by the same material as the first cylindrical portion 110 and the second cylindrical portion 120, and the figure 8 It is formed into a mold, a double spindle type or a peanut type. The tube diameters of the first tube portion 110 and the second tube portion 120 are smaller than the inner diameter of the catheter when the diameter is reduced, and have a size suitable for catheter treatment of atrial septal defect when the diameter is increased. . For example, the cylinder diameters of the first cylinder part 110 and the second cylinder part 120 when the diameter is increased are 5 mm to 80 mm, preferably about 15 mm to 25 mm. Further, the lengths of the first cylindrical part 110 and the second cylindrical part 120 and the density of the knitted tissue of the defect hole closing material 100 are suitable for catheter treatment of atrial septal defect. In addition, the cylinder diameter and length of the 1st cylinder part 110 and the 2nd cylinder part 120 do not need to be the same, What is necessary is just to change so that it may be suitable for the catheter treatment of atrial septal defect.

  It does not specifically limit as a bioabsorbable material which comprises the porous cylindrical layer 160, For example, polyglycolic acid, polylactide (D, L, DL body), polycaprolactone, glycolic acid-lactide (D, L, DL body) ) Copolymer, glycolic acid-ε-caprolactone copolymer, lactide (D, L, DL form) -ε-caprolactone copolymer, poly (p-dioxanone), glycolic acid-lactide (D, L, DL form) ) -Ε-caprolactone copolymer, gelatin, collagen, silk (sericin) and other absorbable polymers. These may be used independently and 2 or more types may be used together. Among these, polyglycolic acid, lactide (D, L, DL) -ε-caprolactone copolymer, glycolic acid-ε-caprolactone copolymer and glycolic acid-lactide (D, L, DL form) -ε-caprolactone copolymer is preferably at least one selected from the group consisting of non-woven fabrics, sponges, films, or composites thereof. In particular, a non-woven fabric can be exemplified as a preferred embodiment.

Further, the material of the porous cylindrical layer 160 may be a biodegradable alloy. An example of such a biodegradable alloy is an alloy based on magnesium as a raw material.
When the porous cylindrical layer 160 is a non-woven fabric, a hydrophilic treatment may be performed. The hydrophilization treatment is not particularly limited, and examples thereof include plasma treatment, glow discharge treatment, corona discharge treatment, ozone treatment, surface graft treatment, or ultraviolet irradiation treatment. Among these, plasma treatment is preferable because the water absorption can be dramatically improved without changing the appearance of the nonwoven fabric layer. The porous cylindrical layer 160 may be a sponge layer or a film layer, or a composite layer of a nonwoven fabric and a sponge layer, a composite layer of a nonwoven fabric and a film layer, a composite layer of a sponge layer and a film layer, a nonwoven fabric, A composite layer of a sponge layer and a film layer may be used.

The porous cylindrical layer 160 holds a drug suitable for catheter treatment of atrial septal defect.
As described above, the defect hole closing material 100 according to the present embodiment has the following characteristics.
(First feature) An hourglass shape, an 8-shaped shape, and a second cylindrical portion 120 squeezed at a substantially central portion 130 (bound with a string of the same material) and a second cylindrical portion 120. It is formed into a continuous spindle type or peanut type.
(Second feature) A cord 140 is provided which is engaged with the second end portion 122 (hooked by the loop of the second end portion 122) and passed through the inside of the cylindrical body to the first end portion 112 side. ing.
(Third feature) The first cylindrical part 110, the second cylindrical part 120, the string 140 (including a string that squeezes the substantially central part 130), and the porous cylindrical layer 160, all of which are living body It is comprised with an absorptive material (the string 140 does not necessarily need to be provided with bioabsorbability).

  Then, according to the first feature and the second feature, the first end portion 112 is fixed and the second end portion 122 is pulled toward the first end portion 112 side by using the string 140, so that it is substantially at the center. The cylinder diameter of the other part of the part 130 (the cylinder diameter of the trunk part in the first cylinder part 110 and the second cylinder part 120) is expanded, or the first cylinder part 110 and the second cylinder part 120 are It approaches with the substantially central portion 130 as the center.

In particular, the defect hole closing material 100 is suitable for catheter treatment of atrial septal defect due to the following effects.
(First Action) The state in which the second end 122 is not pulled toward the first end 112, more specifically, the first end 112 and the second end 122 are separated from each other outside the living body. When pulled in the direction, the tube diameter of the defect hole closing material 100 becomes smaller than the inner diameter of the catheter, and can be set on the catheter.
(Second action) The catheter is set to the catheter, sent to the position of the hole opened in the atrial septum, released in the atrium, the first end 112 is fixed in vivo, and the second end 122 is fixed. When the string 140 is pulled from outside the living body to the first end portion 112 side, the tube diameter of the other portion of the substantially central portion 130 (the tube diameter of the body portion of the first tube portion 110 and the second tube portion 120) is increased. The expanded first tube portion 110 disposed on the right atrial side and the second tube portion 120 disposed on the left atrium side approach each other about the central portion 130 and open into the atrial septum. Can close the hole. Further, when the pulling of the string 140 is released, the expansion and approach of the first cylinder part 110 and the second cylinder part 120 are released to return to the original state, and further, the first end part 112 is connected to another thread. Alternatively, by pulling with a string 140 or pulling with forceps or the like, the tube diameter of the defect hole closing material 100 becomes smaller than the inner diameter of the catheter, and the catheter is reset to the catheter. it can.
(Third Action) Since all of the materials constituting the defect hole closing material 100 are bioabsorbable materials, they are finally absorbed into the living body, so that there is almost no possibility of remote problems.

In order to easily understand such an action, a case where the defect hole closing material 100 is used for catheter treatment of an atrial septal defect will be described with reference to FIGS.
[Usage]
FIG. 3 is a conceptual diagram when the defect hole closing material 100 is used for catheter treatment of atrial septal defect, and FIGS. 4 to 8 are enlarged views of part B of FIG. 3 showing the procedure of this catheter treatment. , Respectively. In the following, only matters specific to the use mode of the defect hole closure material 100 according to the present embodiment will be described, and general items will be described in the same manner as the known catheter treatment for atrial septal defect. Therefore, detailed description here will not be repeated.

  As shown in FIG. 3, a human heart 200 is connected to the right atrium 210 via the right atrium 210, the pulmonary artery and the tricuspid valve 260 connected to the superior and inferior vena cava and receiving venous blood from the whole body, and to the lungs. Two ventricles 2 of the right ventricle 220 for delivering venous blood, the left atrium 230 connected to the pulmonary vein and receiving arterial blood from the lung, and the left ventricle 240 for delivering arterial blood to the whole body via the aorta and the mitral valve 270 Consists of ventricles. Atrial septal defect is a disease in which a defect hole 252 is opened in the atrial septum 250 that separates the right atrium 210 and the left atrium 230. FIG. 3 shows a state where the defect hole closing material 100 is exposed from the catheter 300 for easy understanding.

  First, outside the living body, the first end portion 112 and the second end portion 122 of the defect hole closing material 100 having an appropriate size with respect to the defect hole 252 are pulled in a direction in which the defect hole closing material 100 is separated. The tube diameter is set smaller than the inner diameter of the catheter 300 and set on the catheter 300. The catheter 300 is inserted from the femoral vein, and the defect hole closing member 100 is brought closer to the left atrium 230 side from the right atrium 210 side through the defect hole 252.

  As shown in FIG. 4, the defect hole closing material 100 is stopped at a position where the substantially central portion 130 of the defect hole closing material 100 corresponds to the vicinity of the defect hole 252. When the first end 112 is fixed in the living body and the second end 122 is pulled to the first end 112 side from the outside of the living body 140 as shown in FIGS. The first cylindrical portion 110 and the left atrium that are arranged on the right atrial side with the cylindrical diameter of the other portion 130 (the cylindrical diameter of the trunk portion of the first cylindrical portion 110 and the second cylindrical portion 120) expanded. The second cylindrical portion 120 disposed on the side gradually approaches the center portion 130 (defect hole 252) as a center, and the cylindrical diameter of the first cylindrical portion 110 and the cylindrical portion of the second cylindrical portion 120 The diameter expands. Finally, as shown in FIG. 8, the atrial septum 250 is sandwiched from both sides by the first cylindrical portion 110 and the second cylindrical portion 120, and opened to the atrial septum 250 by the defect hole closing material 100. The defective hole 252 can be closed.

  4 to 8, the first cylindrical portion 110 and the second cylindrical portion 120 are simultaneously expanded in diameter and approached, but the first cylindrical portion 110 is first expanded in diameter. Alternatively, the diameter of the second cylinder part 120 may be enlarged after being brought closer to the second cylinder part 120 and closer to the first cylinder part 110, or conversely, the diameter of the second cylinder part 120 may be enlarged first. It is also possible to enlarge the diameter of the first cylinder part 110 after approaching the first cylinder part 110 and bring it closer to the second cylinder part 120. In this case, for example, the engagement position of the string 140 is changed from the second end 122 to another position, the string 140 is added to the second end 122 and engaged with another part, or the string 140 is engaged. By increasing the number to a plurality, it is possible to easily and variously change the form.

  Thereafter, the catheter 300 and the string 140 are removed from the living body to complete the treatment. Thereby, the defect hole closing material 100 composed entirely of a bioabsorbable material is placed in the living body (precisely, near the defect hole 252). Since all the materials of the defect hole closing material 100 placed in the living body in this way are all bioabsorbable materials, they are finally absorbed into the living body, so there is almost no possibility of a malfunction in the remote period.

Before the defect hole closing material 100 is placed in the living body, it is necessary to fix the shape of the defect hole closing material 100 to the form shown in FIG. In order to fix the defect hole closing material 100 to this form, for example, it is considered that the bioabsorbable fiber 150 is heat-set in vivo while the bioabsorbable fiber 150 has heat-fusibility. It is done.
Further, the defect hole closing material 100 has an advantage that is decisively different from the assembly shown in Patent Document 1. As described above, before fixing the defect hole closing material 100 in vivo in the form shown in FIG. 8, the string 140 is loosened in the living body to form the defect hole closing material 100 in the living body. The configuration shown in FIG. 8 can be returned to the configuration shown in FIG. 4 through the configuration shown in FIGS. Furthermore, by pulling the first end portion 112 with another thread or string 140 or pulling it with forceps or the like, the cylindrical diameter of the defect hole closing material 100 is made smaller than the inner diameter of the catheter 300, and If the catheter 300 is housed inside and returned to the outside of the living body, the catheter treatment can be easily performed from the beginning. For example, a situation can be assumed in which the size of the defect hole closing material 100 is changed and the catheter treatment is started again from the beginning. This is not feasible in the assembly disclosed in Patent Document 1 which can be taken out only by performing a difficult operation using a complicated take-out device once it is fixed in the form as shown in FIG. it is obvious. In the case of the assembly disclosed in Patent Document 1, when such a situation occurs, a highly invasive thoracotomy must be performed.

As described above, according to the defect hole closing material 100 according to the present embodiment, since all of it is composed of a bioabsorbable material and is finally absorbed into the body, there is a possibility of a failure in a remote period. rare. Further, since the cylinder diameter of the defect hole closing material 100 is easily changed, the cylinder diameter of the defect hole closing material 100 can be changed thinly and easily set on the catheter. Further, at the position of the defect hole, the cylinder diameter of the defect hole closing material 100 is changed to be thick and the two cylinders approach each other, and after fixing its form, it is placed in the living body and placed in the atrial septum. The open defect hole can be closed. Furthermore, since the tube diameter of the defect hole closing material 100 can be easily changed in the living body before the form is fixed, the catheter treatment can be easily performed again by setting the catheter again. In this way, minimally invasive treatment is possible.
[Other usage modes]
FIG. 9 to FIG. 11 show a procedure when the defect hole closing material 100 is used for aneurysm catheter treatment. In the following, only matters specific to other usage modes of the defect hole closing material 100 according to the present embodiment will be described, and the general items are the same as the known aneurysm catheter treatment. Therefore, detailed description here will not be repeated. Further, the same description as the above-described use mode (catheter treatment of atrial septal defect) will not be repeated.

  The defect hole closing material 100 is engaged with the substantially central portion 130 side of the first cylindrical portion 110 (it is hooked on the loop opposite to the first end portion 112), and is on the first end portion 112 side. A string 140 passed through the inside of the cylinder is provided. As shown in FIG. 9, the defect hole closing material 100 is stopped at a position where the substantially central portion 130 of the defect hole closing material 100 corresponds to the vicinity of the blood vessel wall 350 of the artery. At this time, the second cylindrical portion 120 is disposed in the aneurysm 352, and the first cylindrical portion 110 is disposed in the artery. When the string 140 is operated from outside the living body so as to expand the tube diameter of the first tube portion 110 while maintaining the shape of the second tube portion 120 in the living body (at least not expanding the diameter) ) As shown in FIG. 10, the cylinder diameter of the first cylinder part 110 is expanded. Furthermore, by continuing this operation, the entrance portion of the aneurysm 352 can be finally closed by the first tube portion 110 as shown in FIG. This prevents arterial blood from flowing into the aneurysm 352.

Here, as shown in FIG. 1 described above, the string 140 is engaged with the second end portion 122 (hanging on the loop of the second end portion 122), and the cylindrical body is extended to the first end portion 112 side. When the string 140 is operated from outside the living body while being fixed inside the central portion 130 while being passed through the inside (when pulled), the shape of the first cylindrical portion 110 is maintained (at least so as not to expand the diameter). The cylinder diameter of the second cylinder part 120 can also be increased. Such use modes are also conceivable depending on the treatment site in the living body.
[First Modification]
FIG. 12 is an overall perspective view of a defect hole closing material (closing plug) 400 which is an example of a medical material according to a first modification of the present invention. The defect hole closing material 400 includes a string 440 engaged in a manner different from that of the string 140 of the defect hole closing material 100 described above. In this defect hole closing material 400, the configuration and operational effects are the same as those of the defect hole closing material 100 except that the manner in which the strings engage is different.

  As shown in FIG. 12, the defect hole closing member 400 is passed through the inside of the cylinder from the first end 112 side to the second end 122 side and engaged with the second end 122 ( Is hooked on the loop of the second end portion 122), is passed through the inside of the cylinder to the first end portion 112 side, is engaged with the first end portion 112 (hangs on the loop of the first end portion 112) The second end 122 is again passed through the inside of the cylindrical body, is re-engaged with the second end 122 (re-hooked by the loop of the second end 122), and the first end A string 440 passed through the inside of the cylinder to the portion 112 side is provided. By pulling the second end 122 toward the first end 112 using the string 440 (same as pulling the first end 112 toward the second end 122), the defect hole closing material is obtained. As in the case of 100, in the defect hole closing material 400, the cylindrical diameter of the other part of the substantially central portion 130 (the cylindrical diameter of the trunk portion in the first cylindrical portion 110 and the second cylindrical portion 120) is expanded, The first cylindrical portion 110 and the second cylindrical portion 120 approach each other about the substantially central portion 130.

In this case, unlike the defect hole closing material 100, the defect hole closing material 400 can maintain the shape of the defect hole closing material 400 only by pulling the string 440 (without fixing the string 440). Thus, in the defect hole closing material 400, the form can be easily held without fixing the string 440.
In this defect hole closing material 400, instead of engaging the double loop of the string 440 with the second end portion 122 (hanging on the loop of the second end portion 122), the second cylindrical portion 120 is substantially omitted. When engaged with the central portion 130 (hooked on the loop opposite to the second end portion 122), the shape of the second cylindrical portion 120 is maintained as described with reference to FIGS. Thus, the cylindrical diameter of the first cylindrical portion 110 can be expanded (at least so as not to increase the diameter), and the shape of the defect hole closing member 400 can be easily maintained without fixing the string 440.

  Further, on the contrary, in this defect hole closing material 400, instead of engaging the single loop of the string 440 with the first end 112 (hanging on the loop of the first end 112), When engaged with the substantially central portion 130 side of the cylindrical portion 110 (hanging on the loop opposite to the first end portion 112), as described with reference to FIGS. 9 to 11, the cylinder diameter of the opposite cylinder part is expanded), and the cylinder diameter of the second cylinder part 120 is expanded while maintaining the shape of the first cylinder part 110 (at least not to increase the diameter). In addition, the shape of the defect hole closing member 400 can be easily held without fixing the string 440.

In many cases, the string 440 in the defect hole closing member 400 is not taken out of the living body after the catheter treatment is completed. In this case, the string 440 must be provided with bioabsorbability.
[Second Modification]
FIG. 13 shows an overall perspective view of a defect hole closing material (closing plug) 500 which is an example of a medical material according to a second modification of the present invention. The defect hole closing material 500 is a modification that can be applied to the defect hole closing material 100 or the defect hole closing material 400 described above. In this defect hole closing material 500,
(1st difference) The point which is not restrict | squeezed in the substantially center part 130 by the string of the same material as the 1st cylinder part 110 and the 2nd cylinder part 120,
(Second Difference) The first end portion 112 is provided with a first collecting portion 510 having a shape protruding toward the outside of the cylindrical body constituting the defect hole closing material 500, and the second end portion 122 side. The second assembly portion 520 having a shape recessed toward the inside of the cylindrical body constituting the defect hole closing material 500,
Are different, and are identical in other points. That is, the configuration and operational effects other than the above two differences are the same as those of the defect hole closing material 100 or the defect hole closing material 400.

In the following, these differences will be described in detail.
In the defect hole closing material 100 and the defect hole closing material 400, the first tube portion 110 and the second tube portion 120 are squeezed (tied up) at the substantially central portion 130 with the same material as that of the first tube portion 110 and the second tube portion 120. At the time of attachment to the affected part and / or to the affected part (defect hole closing material 100 or defect hole closing at a position where the substantially central portion 130 of the defect hole closing material 100 or the defect hole closing material 400 corresponds to the vicinity of the defect hole 252) When the material 400 is stopped), the first cylinder part 110 and the second cylinder part 120 become unstable and may be difficult to handle.

On the other hand, in the defect hole closing material 500, the first cylindrical portion 110 and the second cylindrical portion 120 are not squeezed (not tied) at the substantially central portion 130 by the same material string, and A first aggregate portion 510 is formed on the first end portion 112 side of the cylindrical portion 110, and a second aggregate portion 520 is formed on the second end portion 122 side of the second cylindrical portion 120. The first aggregate portion 510 and / or the second aggregate portion 520 is a knitted tissue formed by the bioabsorbable fibers 150 and is an aggregate of the bioabsorbable fibers 150. For this reason, the substantially central portion 130 becomes thicker,
Since the first cylinder part 110 and the second cylinder part 120 can be prevented from becoming unstable when attached to the catheter 300 and / or attached to the affected part, handling is facilitated. .

In addition, when the first end portion 112 is provided with the first gathering portion 510 of the shape protruding toward the outside of the cylindrical body constituting the defect hole closing material 500 on the first end portion 112 side, In addition, the first gathering portion 510 serves as a guide to the inner wall 310 of the catheter 300, and the operation of housing the defect hole closing material 500 in the catheter 300 becomes easy.
Furthermore, since the second end portion 122 is provided with the second collecting portion 520 having a shape recessed toward the inside of the cylindrical body constituting the defect hole closing material 500, the defect hole closing material 500 is provided. When the catheter 300 is accommodated, the diameter of the second cylindrical portion 120 is easily reduced (easily thinned), and the operation of accommodating the defect hole closing material 500 in the catheter 300 is facilitated.

Here, although not limited thereto, in the first aggregate portion 510 and the second aggregate portion 520, the bioabsorbable fiber 150 is bound (or bound) or bonded by heat setting. They are adhered by an adhesive or the like that does not inhibit biodegradability to form an aggregate.
Moreover, although not limited, the defect hole closing material 100 according to the above-described embodiment, the defect hole closing material 400 according to the first modification described above, or the defect hole closing according to the second modification described above. When the material 500 is housed in the catheter 300, a string or the like is engaged with the first end 112 side, and the string or the like is pulled from the opposite side of the opening 320 of the catheter 300 to remove the defect hole closing material. Store in 300. In this case, when the string or the like is engaged with the first end 112 side, the string 140 is engaged with the second end 122 as described above (hangs on the loop of the second end 122). ) Is processed in this way.

  The embodiment disclosed this time should be considered as illustrative in all points and not restrictive. The scope of the present invention is defined by the terms of the claims, rather than the description above, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.

  INDUSTRIAL APPLICABILITY The present invention is suitable for a medical material set on a catheter to treat a defect (hole, aneurysm) formed in a living tissue, and can be released and placed at a treatment site to enable a minimally invasive treatment. Even if the medical material remains in the body, it is particularly preferable in that there is almost no possibility of a malfunction in the remote period.

100, 400, 500 Medical materials (closure plugs)
DESCRIPTION OF SYMBOLS 110 1st cylinder part 112 1st edge part 120 2nd cylinder part 122 2nd edge part 130 Approximate center part 140,440 String 150 Bioabsorbable fiber 160 Porous cylindrical layer 200 Heart 250 Atrial septum 252 Defect hole 300 catheter 350 (arterial) vessel wall 352 aneurysm

Claims (7)

A medical material formed by a tubular body of a knitted structure using a wire,
The cylindrical diameter of the substantially central portion of the cylindrical body has a shape smaller than the cylindrical diameter of the other part,
The knitted tissue at both ends in the longitudinal direction of the cylindrical body of the medical material forms a first aggregated portion with one end protruding toward the outside of the cylindrical body, and the other end of the cylindrical body Forming a second gathering part that is recessed inward ,
A first cylindrical portion on the first end side and a second cylindrical portion on the second end side are formed around the substantially central portion,
From the first end side to the second end side is passed through the inside of the cylindrical body, engaged with the second end part and passed through the inside of the cylindrical body to the substantially central part, It is engaged with the substantially central portion and passed again through the inside of the cylinder to the second end side, and is re-engaged with the second end portion and again into the inside of the cylinder to the first end side. medical material characterized in Rukoto provided with the passed string. By securing the pre Symbol first end pulls the second end portion which is the other end to the first end portion side, the cylinder diameter of the other portion is characterized in that it is extended The medical material according to claim 1. By securing the pre Symbol first end pulls the second end portion which is the other end to the first end portion side, and the first cylindrical portion and said second cylindrical portion is the The medical material according to claim 1, wherein the medical material approaches near a substantially central portion. By pre-Symbol securing the first end pulls the substantially central portion side of the first cylindrical portion to the first end side, characterized in that the cylinder diameter of the first cylindrical portion is extended The medical material according to claim 1. The medical material according to any one of claims 1 to 4 , wherein the shape is an hourglass shape, an 8-shaped shape, or a double spindle shape. The medical material according to any one of claims 1 to 5 , wherein the wire is a bioabsorbable material. The porous cylindrical layer comprised from either the nonwoven fabric which consists of bioabsorbable material, sponge, a film, and these composites is arrange | positioned at the inner surface of the said cylindrical body, It is characterized by the above-mentioned. The medical material according to claim 6 .

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